Evaluation of the Safety and Performance of the Hearttouch™ Electrophysiology Mapping Catheter and Naviblaze™ Electrophysiology Ablation Catheter in a Porcine Model

Abstract

The objective of this study was to evaluate the safety and performance of the HeartTouch™ Electrophysiology Mapping Catheter and NaviBlaze™ Electrophysiology Ablation Catheter in various heart chambers (right atrium, right ventricle, left atrium, and pulmonary veins) in a porcine model. The study utilized two female pigs. The procedures were carried out under anesthesia with standard percutaneous access through the 7F sheath which was inserted into the internal jugular vein, two sheaths of 8F into the right femoral vein and one 5F sheath into the left femoral artery. The study involved multiple runs of mapping and ablation catheter tests to assess both mapping accuracy and lesion effectiveness. Mapping catheter testing demonstrated successful navigation and signal recording across various heart chambers, confirming the efficacy of device in identifying electrophysiological landmarks. Ablation catheter testing involved both non-irrigated and irrigated catheters, resulting in significant impedance reductions at target sites, confirming effective tissue interaction and lesion creation. Necropsy images revealed visible ablation lesions, further corroborating the catheter's effectiveness. No morbidity or mortality was observed in the animals, and clinical signs remained normal throughout the study. The findings suggest that both the HeartTouch™ Mapping Catheter and NaviBlaze™ Ablation Catheter are effective tools for precise mapping and targeted ablation, supporting their potential for clinical use in treating arrhythmias and advancing electrophysiological research